Supernus planning NDA for ADHD candidate following Phase III readouts

Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) said SPN-812 met the primary endpoint in the Phase III P301 and P303 trials to treat children with ADHD. The company plans to submit an NDA to FDA in 2H19 for the selective norepinephrine reuptake inhibitor (SNRI) to treat ADHD.

The double-blind, U.S. P301 and P303 trials enrolled 477 and 313 ADHD patients ages 6-11, respectively, to receive placebo or once-daily oral SPN-812. On P301's primary endpoint, SPN-812 significantly reduced ADHD Rating Scale-5 (ADHD-RS-5) total score from baseline to week six by 16.6 points at the 100 mg dose (p=0.0004) and by 17.7 points at the 200 mg dose (p<0.0001) vs. 10.9 points for placebo. On P303's primary endpoint, SPN-812 significantly reduced ADHD-RS-5 total score from baseline to week eight by 17.6 points at the 200 mg dose (p=0.0038) and by 17.5 points at the 400 mg dose (p=0.0063) vs. 11.7 points for placebo...